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Original Research Article Background: Diclofenac is the most commonly prescribed drug in clinical settings for the management of pain and inflammation. Gastrointestinal toxicity is a major clinical limitation of Diclofenac. A number of studies describe NASIDs as the leading causes of adverse drug reactions (ADRs). Objectives: The main aim of this study was to evaluate the prescribing pattern of Diclofenac and to monitor the ADRs in orthopaedic IP patients with various comorbidities. Materials & Methods: A prospective observational study was planned and conducted in the Department of Orthopaedics IPD of a tertiary care teaching hospital, RIMS. Patient data relevant to the study was obtained using a standard data collection form designed. A predesigned proforma of CDSCO (central Drug Standards Control Organisation) was used to record ADR. The causality was analyzed by using WHO causality assessment scale and the severity was analyzed by using the Hartwing and Siegel scale. Results: NSAID (Diclofenac) was commonly prescribed for osteoarthritis (10%), rheumatoid arthritis (11.67%), Fractures (45%), lower backache (10%), Spondylosis (8.33%), and osteomyelitis (15%). Nearly 63.64% (n=7) of the ADRs were reported by men and 36.36% (n=3) were reported by females. The reactions which were observed were nausea, vomiting, gastritis, abdominal discomfort, diarrhoea and headache. The most commonly reported ADR was gastritis and the system which was involved was the gastro-intestinal system with diclofenac. As per WHO causality assessment scale, 11.67% ADRs were assessed as “possible” ADRs and 5% as “probable” ADRs. The severity assessment scale revealed that 100% were mild and that moderate and severe ADRs were not identified. Conclusion: Knowledge of potential adverse effects and standard prescription guide lines will play pivotal role in rational prescription of NSAIDs (diclofenac). Regular prescription audits with feedback to prescribers can alter prescribing behaviour towards good prescribing practices.

Adverse Drug Reaction Profile and Medication Chart Review in Orthopaedic Patients Receiving Diclofenac Sodium at a Tertiary Care Urban Hospital